Reporting to the Director of Regulatory Affairs, YOU will monitor and analyzes issues in various phases of government regulatory procedures and identifies trends important to the organization for use by management in decision making. Also, you?re responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Regulatory Knowledge (as applicable)
- Regulatory history, guidelines, policies, standards, practices, requirements and precedents
- Regulatory agency structure, processes and key personnel
- Principles and requirements of applicable product laws (Food/Infant Formula)
- Notification/Submission/registration types and requirements, US, EU and ROW
- GxPs (GCPs, GLPs, GMPs)
- Principles and requirements of promotion, advertising and labeling - Note: This knowledge may be developed through tenure in this position.
- Learn to write and edit technical documents
- Research and locate information on regulatory requirements and products
- Advanced degree in the biological or food/pharmaceutical or regulatory sciences preferred.
- 5-8years of relevant regulated industry experience including experience in regulatory affairs is required.